Definition: Quality system focused on ensuring pharmaceutical products are consistently stored, transported, and handled under suitable conditions as required by regulatory authorities.
WHO GDP Guidelines (adapted by SAHPRA for South Africa)
Key Requirements:
Quality Management:
- Written procedures for all operations
- Trained and qualified personnel
- Risk management approach
- Regular audits and reviews
Temperature Control:
- Temperature mapping of facilities and vehicles
- Continuous monitoring with calibrated equipment
- Deviation investigation and reporting
- Validated cold chain packaging
Documentation:
- Batch records and traceability
- Temperature logs and reports
- Deviation and CAPA (Corrective Action/Preventive Action) records
- Supplier and customer qualification
Qualification:
- IQ/OQ/PQ for equipment and vehicles
- Transport lane qualification
- Packaging qualification
Why It Matters:
- SAHPRA licensing requirement for pharmaceutical distributors
- Required by pharmaceutical manufacturers
- Expected by healthcare providers
- Critical for patient safety
Related Terms: SAHPRA, IQ/OQ/PQ, Temperature Mapping, Qualified Transport, Pharmaceutical Range
Resources: GDP Compliance Guide
Find Services: GDP-compliant pharmaceutical distributors and consultants